Clinical Trials Lead FDA to Increase Label Warnings on Canagliflozin
After clinical trial data showing an increased risk for bone fractures, the U.S. Food and Drug Administration (FDA) has decided to update the labels on Canagliflozin, a drug used to treat type 2 diabetes.
About the Label Update
According to Medscape, the label for Canagliflozin had already stated that there was a risk for bone fractures; however, after reviewing the findings of the clinical trials, the FDA felt the need to update and strengthen that warning.
The newly updated label now has a more comprehensive warning with precautionary information. It also has new information about what could cause the fractures: decreased bone mineral density in the hips and the lower spine.
Healthcare professionals are now being called to add this information to the decision process used when deciding what drug to put a patient on.
Data from the Clinical Trials
- The FDA conducted nine clinical trials with about 85 weeks (about 1 year and 7½ months) of exposure to canagliflozin.
- The incidence rates of bone fractures were 1.1 to 1.5 per 100 patient-years of exposure.
- The bone mineral density data came from another FDA trial consisting of 714 elderly patients diagnosed with type 2 diabetes.
- Their average age was 64 years, and the range of ages was between 55-80.
- The patients were randomly assigned either a placebo or canagliflozin.
- The patients receiving canagliflozin showed a declining bone mineral density at about .9% or 1.2% (depending on the 100 mg or 300 mg dosage).
Possibility for Additional Reviews
The recent findings in canagliflozin may lead the FDA to evaluate and study more drugs in the same class, the sodium glucose cotransporter 2 (SGLT2) inhibitor class.
Other drugs in the class include dapagliflozin and empagliflozin